Events

Recall of Device Recall Medtronic Model 5392 DualChamber Temporary External Pulse Generator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Inc. Cardiac Rhythm Disease Management.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70763
  • Event Risk Class
    Class 2
  • Event Number
    Z-1356-2015
  • Event Initiated Date
    2015-03-17
  • Event Date Posted
    2015-03-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134632
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pulse-generator, pacemaker, external - Product Code DTE
  • Reason
    Possible performance issue when used with specific aa-sized (lr6) batteries. the negative terminal of a commercially available aa (lr6) battery did not maintain a sufficient connection with the battery drawer electrical contact. this issue could prevent the epg from powering on or cause the epg to abruptly lose primary battery power, potentially stopping delivery of pacing therapy.
  • Action
    Medtronic sent an "Urgent Medical Device Correction" letter dated March 2015 to affected customers. The letter was addressed to Risk Manager or Health Care Professional. The letter described the Issue and Customer Actions to be taken. The letter requested customers to complete and return the Customer Confirmation Certificate. For questions contact your Medtronic representative, for technical questions call Instrument Technical Service at 800-638-1991.

Device

Device Recall Medtronic Model 5392 DualChamber Temporary External Pulse Generator
  • Model / Serial
    serial numbers equal or lower than DJH009999P
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of: AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MI, MM, MS, MO, MT, NE NV,N, NM, NY, NC, ND, OH,OK, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY, PR, VI and the countries of:Australia, Austria, Bahamas, Belgium, Bolivia ,Botswana, Brazil ,Brunei, Darussalam, Bulgaria, Burkina Faso, Canada, Colombia, Croatia, Cyprus, Czech Republic, Denmark,, Dominican Republic, Egypt, France, Georgia, Germany, Greece, Guyana, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Korea, Kuwait, Lebanon, Luxembourg, Macedonia, Malaysia, Mauritius, Morocco, Mozambique, Namibia, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Papua, New Guinea, Peru, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, St. Pierre and Miquelon,Sweden, Switzerland, Tanzania, Thailand, Trinidad and Tobago, Tunisia, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, and Yemen. .
  • Product Description
    Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. || Product Usage: || The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel. The temporary pacemaker can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic, or diagnostic purposes. The temporary pacemaker must be used in an environment where the patient is monitored continuously to ensure that it is operating properly and delivering appropriate therapy to the patient. Specific indications for temporary cardiac pacing include, but are not limited to, the following: - Complete heart block - Sinus bradycardia - Sick sinus syndrome - Bradycardia with congestive heart failure - Atrial and/or ventricular arrhythmias - Cardiac arrest - Support, management, and evaluation of a patient before permanent pacemaker implantation - Support during permanent pacemaker replacement - Cardiac complications during invasive or surgical procedures - Support following cardiac surgery - Acute myocardial infarction complicated by heart block - Atrial tachyarrhythmias that require high-rate burst pacing for treatment
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Disease Management

Manufacturer

Medtronic Inc. Cardiac Rhythm Disease Management
  • Manufacturer Address
    Medtronic Inc. Cardiac Rhythm Disease Management, 8200 Coral Sea St NE, Saint Paul MN 55112-4391
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA